Israel - English - Ministry of Health

novartis israel ltd - capmatinib as dihydrochloride monohydrate - film coated tablets - capmatinib as dihydrochloride monohydrate 150 mg - capmatinib - tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have a mutation that leads to mesenchymal-epithelial transition (met) exon 14 skipping as detected by an approved test.

Israel - English - Ministry of Health

novartis israel ltd - capmatinib as dihydrochloride monohydrate - film coated tablets - capmatinib as dihydrochloride monohydrate 200 mg - capmatinib - tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have a mutation that leads to mesenchymal-epithelial transition (met) exon 14 skipping as detected by an approved test.

Canada - English - Health Canada

novartis pharmaceuticals canada inc - capmatinib (capmatinib hydrochloride) - tablet - 150mg - capmatinib (capmatinib hydrochloride) 150mg

Canada - English - Health Canada

novartis pharmaceuticals canada inc - capmatinib (capmatinib hydrochloride) - tablet - 200mg - capmatinib (capmatinib hydrochloride) 200mg

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - capmatinib hydrochloride (unii: c2a374o70x) (capmatinib - unii:ty34l4f9oz) - tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have a mutation that leads to mesenchymal-epithelial transition (met) exon 14 skipping as detected by an fda-approved test. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , tabrecta can cause fetal harm when administered to a pregnant woman. there are no available data on tabrecta use in pregnant women. oral administration of capmatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures less than the human exposure based on auc at the 400 mg twice daily clinical dose (see data ). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in rats, maternal toxicity (reduced body weight gain and food consumption) occurred at 30 mg/kg/day (approximately 1.4 times the human exposure based on auc at the 400 mg twice daily clinical dose). fetal effects included reduced fetal weights, irregular/incomplete ossification, and increased incidences of fetal malformations (e.g., abnormal flexure/inward malrotation of hindpaws/forepaws, thinness of forelimbs, lack of/reduced flexion at the humerus/ulna joints, and narrowed or small tongue) at doses of ≥ 10 mg/kg/day (approximately 0.6 times the human exposure based on auc at the 400 mg twice daily clinical dose). in rabbits, no maternal effects were detected at doses up to 60 mg/kg/day (approximately 1.5 times the human exposure based on auc at the 400 mg twice daily clinical dose). fetal effects included small lung lobe at ≥ 5 mg/kg/day (approximately 0.016 times the human exposure based on auc at the 400 mg twice daily clinical dose), and reduced fetal weights, irregular/incomplete ossification and increased incidences of fetal malformations (e.g., abnormal flexure/malrotation of hindpaws/forepaws, thinness of forelimbs/hindlimbs, lack of/reduced flexion at the humerus/ulna joints, small lung lobes, narrowed or small tongue) at the dose of 60 mg/kg/day. risk summary there are no data on the presence of capmatinib or its metabolites in either human or animal milk or its effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with tabrecta and for 1 week after the last dose. based on animal data, tabrecta can cause malformations at doses less than the human exposure based on auc at the 400 mg twice daily clinical dose [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status for females of reproductive potential prior to starting treatment with tabrecta. contraception females advise females of reproductive potential to use effective contraception during treatment with tabrecta and for 1 week after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with tabrecta and for 1 week after the last dose. safety and effectiveness of tabrecta in pediatric patients have not been established. in geometry mono-1, 61% of the 373 patients were 65 years or older and 18% were 75 years or older. no overall differences in the safety or effectiveness were observed between these patients and younger patients. no dosage adjustment is recommended in patients with mild (baseline creatinine clearance [clcr] 60 to 89 ml/min by cockcroft-gault) or moderate renal impairment (clcr 30 to 59 ml/min) [see clinical pharmacology (12.3)] . tabrecta has not been studied in patients with severe renal impairment (clcr 15 to 29 ml/min).

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - carcinoma, non-small-cell lung - antineoplastic agents - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - capmatinib dihydrochloride monohydrate eqv capmatinib - tablet, film coated - capmatinib dihydrochloride monohydrate eqv capmatinib 150mg

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - capmatinib dihydrochloride monohydrate eqv capmatinib - tablet, film coated - capmatinib dihydrochloride monohydrate eqv capmatinib 200mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - capmatinib -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - capmatinib -